Ventilator LungNCT03728010
Electrical Impedance Tomography in One-Lung Ventilation
An observational study of Ventilator Lung, run by University of Chile at 1 site in Chile.
Trial summary
Mechanical ventilation can cause damage to the lung parenchyma, this is known as ventilatory induce lung injury (VILI).To avoid this damage, ventilatory strategies have been created, focused on the reduction of tidal volume, airway pressures and use of PEEP (positive end-expiratory pressure), which together are called… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventilator Lung
- What is being tested?
- Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurement
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 7 Dec 2018to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients between 18 and 75 years old. With pulmonary diseases that require thoracic surgery with one-lung ventilation.
Who may be able to join
- ASA (American Society of Anesthesiologists) classification I-III
- Age 18-75 Years
- Elective thoracic surgery
- One-Lung Ventilation
- Healthy non ventilated lung
Who cannot join
- ASA classification > III
- BMI (Body mass index) > 30
- Emergency surgery
- Pregnancy
- Patients includes in other protocols
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
University of Chile Clinical Hospital
Santiago, 562
Roberto A Gonzalez, MD, 56999397515, robgonzalez@uchile.cl
Karen N Venegas, MD, 56977062804, venegaslandaida@gmail.com
About this study
Official title: Tidal Volume and PEEP Titration in One-Lung Ventilation With Electrical Impedance Tomography
Mechanical ventilation can cause damage to the lung parenchyma, this is known as ventilatory induce lung injury (VILI).To avoid this damage, ventilatory strategies have been created, focused on the reduction of tidal volume, airway pressures and use of PEEP (positive end-expiratory pressure), which together are called "protective ventilation".
Although ventilation with protective parameters seems to reduce VILI in one-lung ventilation, the optimal parameters are not clear.
Read the detailed description
This research aims to describe the ventilation, perfusion and pulmonary mechanics on one-lung ventilation with different levels of tidal volume and PEEP.
An extreme situation of VILI occurs in thoracic surgery, where the atelectasis of a lung is required, ventilating throughout the surgery only the contralateral one. This generates an inflammatory state, with the release of alveolar cytokines from both the non-ventilated and ventilated lungs, which potentiates the development of damage in the lung parenchyma. In addition, one lung ventilation has traditionally been performed with high tidal volume (Vt) values and low PEEP. In this context, the development of VILI is even more probable, so extreme measures of protection in this kind of ventilation are necessary.
The electrical impedance tomography will allow the investigators to obtain a visual and quantitative representation of the areas of ventilation and perfusion of the lung. By relating the tidal volume and PEEP with the tomographic results, it is expected to define mechanical ventilation parameters that achieve the best ventilation/perfusion ratio for patients in one-lung ventilation. Specifically, analyze the distribution and deformation of the ventilated areas in the different lung regions and its correlation with respiratory mechanics and volumetric capnography. This will allow the investigators to make a better definition of the tidal volume and PEEP in patients undergoing one-lung ventilation.
.
- Conditions
- Ventilator Lung
- Being tested
- Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurement
- Keywords
- Electrical impedance tomography, One-lung ventilation, Protective ventilation, Ventilator- Induce Lung injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurementDiagnostic test
After general anesthesia, patients will be ventilated with three tidal volume level (4, 6 and 8 cc / Kg / IBW), in two levels of PEEP, 6 cm2 H20, and best PEEP, the latter obtained after a recruitment maneuver and decremental titration.
| Study group | Role | What they receive |
|---|---|---|
| One-Lung Ventilarion | Thoracic surgery cases with one-lung ventilation strategy. Receives: Diagnostic Test: Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation/ perfusion ratio
Electrical impedance tomography.
Measured: 1 hour
Pulmonary mechanics
Airway pressure ,esophageal pressure measurement.
Measured: 1 hour
Arterial gas measurement
5 samples per patient
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start7 Dec 2018
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventilator LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Gonzalez Cornejo, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728010
- Sponsor's protocol ID
- EITOLV001
- Status last verified
- May 2023
- First submitted
- 9 Oct 2018
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gattinoni L, Protti A, Caironi P, Carlesso E. Ventilator-induced lung injury: the anatomical and physiological framework. Crit Care Med. 2010 Oct;38(10 Suppl):S539-48. doi: 10.1097/CCM.0b013e3181f1fcf7.
PubMed 21164395Pinhu L, Whitehead T, Evans T, Griffiths M. Ventilator-associated lung injury. Lancet. 2003 Jan 25;361(9354):332-40. doi: 10.1016/S0140-6736(03)12329-X.
PubMed 12559881Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PubMed 23902482El Tahan MR, Pasin L, Marczin N, Landoni G. Impact of Low Tidal Volumes During One-Lung Ventilation. A Meta-Analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2017 Oct;31(5):1767-1773. doi: 10.1053/j.jvca.2017.06.015. Epub 2017 Jun 7.
PubMed 28843606
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tidal Volume and PEEP Titration in One-Lung Ventilation With Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT03728010
- Acronym / sponsor ID
- EITOLV001
- Conditions
- Ventilator Lung
- Keywords
- Electrical impedance tomography, One-lung ventilation, Protective ventilation, Ventilator- Induce Lung injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanical ventilation can cause damage to the lung parenchyma, this is known as ventilatory induce lung injury (VILI).To avoid this damage, ventilatory strategies have been created, focused on the reduction of tidal volume, airway pressures and use of PEEP (positive end-expiratory pressure), which together are called "protective ventilation".
Although ventilation with protective parameters seems to reduce VILI in one-lung ventilation, the optimal parameters are not clear.
Detailed description
This research aims to describe the ventilation, perfusion and pulmonary mechanics on one-lung ventilation with different levels of tidal volume and PEEP.
An extreme situation of VILI occurs in thoracic surgery, where the atelectasis of a lung is required, ventilating throughout the surgery only the contralateral one. This generates an inflammatory state, with the release of alveolar cytokines from both the non-ventilated and ventilated lungs, which potentiates the development of damage in the lung parenchyma. In addition, one lung ventilation has traditionally been performed with high tidal volume (Vt) values and low PEEP. In this context, the development of VILI is even more probable, so extreme measures of protection in this kind of ventilation are necessary.
The electrical impedance tomography will allow the investigators to obtain a visual and quantitative representation of the areas of ventilation and perfusion of the lung. By relating the tidal volume and PEEP with the tomographic results, it is expected to define mechanical ventilation parameters that achieve the best ventilation/perfusion ratio for patients in one-lung ventilation. Specifically, analyze the distribution and deformation of the ventilated areas in the different lung regions and its correlation with respiratory mechanics and volumetric capnography. This will allow the investigators to make a better definition of the tidal volume and PEEP in patients undergoing one-lung ventilation.
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One-Lung Ventilarion | – | Diagnostic Test: Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurementThoracic surgery cases with one-lung ventilation strategy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients between 18 and 75 years old. With pulmonary diseases that require thoracic surgery with one-lung ventilation.
Key inclusion criteria (5 listed)
- ASA (American Society of Anesthesiologists) classification I-III
- Age 18-75 Years
- Elective thoracic surgery
- One-Lung Ventilation
- Healthy non ventilated lung
Key exclusion criteria (5 listed)
- ASA classification > III
- BMI (Body mass index) > 30
- Emergency surgery
- Pregnancy
- Patients includes in other protocols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurementAfter general anesthesia, patients will be ventilated with three tidal volume level (4, 6 and 8 cc / Kg / IBW), in two levels of PEEP, 6 cm2 H20, and best PEEP, the latter obtained after a recruitment maneuver and decremental titration. | Diagnostic test | One-Lung Ventilarion |
Primary outcome
Ventilation/ perfusion ratio
Time frame: 1 hour
Electrical impedance tomography.
Pulmonary mechanics
Time frame: 1 hour
Airway pressure ,esophageal pressure measurement.
Arterial gas measurement
Time frame: 20 minutes
5 samples per patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 21164395Gattinoni L, Protti A, Caironi P, Carlesso E. Ventilator-induced lung injury: the anatomical and physiological framework. Crit Care Med. 2010 Oct;38(10 Suppl):S539-48. doi: 10.1097/CCM.0b013e3181f1fcf7.
- Background: PubMed 12559881Pinhu L, Whitehead T, Evans T, Griffiths M. Ventilator-associated lung injury. Lancet. 2003 Jan 25;361(9354):332-40. doi: 10.1016/S0140-6736(03)12329-X.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
- Background: PubMed 23902482Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
- Background: PubMed 28843606El Tahan MR, Pasin L, Marczin N, Landoni G. Impact of Low Tidal Volumes During One-Lung Ventilation. A Meta-Analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2017 Oct;31(5):1767-1773. doi: 10.1053/j.jvca.2017.06.015. Epub 2017 Jun 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Lung, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Gonzalez, MD (56999397515, robgonzalez@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation/ perfusion ratio (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03728010, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.